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Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma

2019-11-13 17:56:46 | BioPortfolio

Summary

This phase I trial studies the best dose of copanlisib when given together with combination chemotherapy (R-GCD) in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or grade 3b follicular lymphoma that has come back (relapsed) after 1 prior line of therapy. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as rituximab, gemcitabine, carboplatin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib together with R-GCD as second line therapy may improve the complete response rate for patients with diffuse large B-cell lymphoma or follicular lymphoma.

Description

This is a dose-escalation study of copanlisib.

Patients receive copanlisib intravenously (IV) and gemcitabine IV on days 1 and 8, carboplatin IV and rituximab IV on day 1, and dexamethasone orally (PO) in the morning (AM) or 30-60 minutes prior to chemotherapy on days 1-4. Patients also receive pegfilgrastim subcutaneously (SC) on day 8 or 9. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 1 year.

Study Design

Conditions

Grade 3b Follicular Lymphoma

Intervention

Copanlisib, Gemcitabine, Carboplatin, Dexamethasone, Rituximab, Pegfilgrastim

Location

Fred Hutch/University of Washington Cancer Consortium
Seattle
Washington
United States
98109

Status

Not yet recruiting

Source

University of Washington

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-13T17:56:46-0500

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